J2S-MC-GZMH: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD 1)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522308-25-00

Enrollment

Registered

2026-06-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Brief summary

Time to Relapse Defined as the Number of Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)

Interventions

DRUGBrenipatide

DRUGPlacebo to match LY

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to Relapse Defined as the Number of Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 6, 2026